Many meat producers, in response to regulatory directives and Guidelines, and customer/consumer demands, have adopted a sampling plan or methodology for the testing of ‘trim,’ precuts, and/or of ground raw materials and final products for: pathogens, including E. coli O157:H7, Salmonella, Listeria, Staphylococcus, etc.; spoilage organisms, including clostridial and Pseudomonas species, etc.; and indicator organisms, including generic E. coli, fecal coliforms, total coliforms, etc., and indicator substances including glial fibrillary acidic protein (GFAP) associated with central nervous system tissue. The end result of current testing using the presently available plans provides results that are obtained too late to afford improvement of the quality of the product batch from which the samples were taken. Such prior art plans or methodologies are good-faith attempts to comply with the guidelines and consumer demands, but the these plans fall short of achieving a statistically robust ‘lot’ acceptance criteria that would represent a significant improvement in the microbiological quality of foods.
Generally, carcass processing in the slaughter and meat packaging industry proceeds by killing the animals, de-hiding, splitting the carcasses into respective half-carcasses, chilling of half-carcasses, and subsequent reduction and fabrication (e.g., processing of the carcasses by cutting to harvest various primal and sub-primals, which results in production of trims). While various primal and sub-primal cuts of meat are packaged and shipped, meat trimmings and other appropriate cuts which are to be used in ground beef production are placed into respective packing units referred to as ‘combos’ or ‘combo-bins,’ each containing about 2,000 lbs of trimmings, corresponding to a plurality of different carcasses. A prior art ‘packing-Lot’ is composed of five ‘combo-bins.’ The packing-Lots are the final aggregates of product to be shipped to customers or used in-house for further conversion to ground beef.
Prior art pathogen-testing plans are actually either trim-testing plans, final product testing plans, or both, involving random and incomplete sampling at the ‘packing-Lot’ level; that is, testing of trim samples near the end of the production chain (as they enter the bins or after binning, or testing of the ground products by taking samples at given time intervals. A typical trim-testing plan involves analysis of ‘five-combo-lot’ units, and comprises analysis of a single composite-Lot sample of about 375 g, prepared by combining five combo-bin samples (about 75 g each), in each case corresponding to one to five randomly-selected pieces from each combo-bin, such that, on average 5-25 pieces representing the five combo-bins are in the composite sample. Given that a combo-bin is comprised of pieces of a plurality of carcasses, the test results under these prior art systems reflect random and incomplete sampling; that is, only a small fraction of the carcasses are represented in the test results, particularly where, as is true of many such plans, only a sub-fraction of the composite-Lot sample is used for the pathogen-testing assay (e.g., when large pieces of trim are collected). For example, for ground beef production, final product testing comprises taking ground beef samples at given time intervals (e.g., every 10-30 minutes) and compositing a number of samples into one composite sample.
Generally, one of several methods of analysis has been used for pathogen detection after sampling at the packing-Lot level: (1) Immunochemical based detection (e.g., ELISA based immunoassays) following enrichment (e.g., for E. coli O157:H7); (2) Nucleic acid-based (e.g., DNA-based, such as PCR-analysis) detection methods following enrichment (e.g., for E. coli O157:H7), wherein an appropriate medium is inoculated with a composite-Lot sample; and (3) target organisms can be detected by enrichment, followed by immunomagnetic separation followed by plating, immunochemical or DNA based detection. Typically, the levels of sensitivity of most of these methods are set at about 1 colony forming unit (cfu)/25 g of sample.
Typically, to allow time for trim testing results to be obtained, such sampling plans require additional (in addition to initial chilling of the split-carcasses, and the time taken during the processing of the carcasses (fabrication)) ‘holding’ of the trim prior to use. Such holding of the trim will typically add 12 to 24 hrs of extra refrigeration storage time/capacity, and uses up about a day of the product shelf-life.
Additionally, a particularly problematic aspect of prior art plans is that they are reactive; that is, they neither allow for meaningful preemptive (do not prevent cross-contamination during trimming) or remedial (not practical to remediate at the trim level) actions, nor do they provide for sufficient confidence in product safety.
Therefore, despite good-faith efforts, there is a lack of adequate public health protection under prior art sampling plans, because these plans do not insure against acceptance of defective lots. The prior art sampling plans are reactive, and by the time a ‘positive’ lot is identified, the respective contamination has moved across the fabrication and packaging areas increasing the likelihood of cross-contamination of multiple batches of products. Additionally, by the time positive lots have been identified, the products have moved through fabrication and there can be no remedial action, because it is impractical to sterilize at the sub-primal trim level. Rather the options are destruction (e.g., rendering) or cooking of the respective product lots by a commercial cooker.
However, such procedures will not ensure the safety of other lots of products that have either been contaminated by the positive-testing lot, or that are in fact positive, but have nonetheless tested negative by virtue of the absence of a statistically robust sampling plan (i.e., by virtue of using random and incomplete sampling of the trim-testing regime). Moreover, prior art plans are substantially disruptive to commerce, because they require increased cold storage time and capacity, disrupt shipping (e.g., recalls), and increase the hold-time before-processing-all of which add significant costs, and reduce product shelf-life. Furthermore, any Lot identified as contaminated will lose all or a significant portion of its value.
Therefore, there is a pronounced need in the art, and particularly in the slaughter and meat-packing industry, for monitoring and verification methods that are more statistically robust, and thus improve and adequately insure the safety of processed food products.
There is a pronounced need in the art for improved monitoring, verification, and remediation methods that can be implemented without major disruption to the production process and that are cost-effective.
There is a pronounced need in the art for improved monitoring, verification, and remediation methods that preclude cross-contamination along the production line (during fabrication).
There is a pronounced need in the art for improved monitoring, verification, and remediation methods that can be used to identify defective lots of products at early stages (carcass stage as opposed to trim or final products) so that they can be sanitized/reconditioned retested and released.